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The MOSS VRS Spinal System is intended to provide immobilization of spinal segments in sketally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities of the thoracic, lumbar and sacral spine.

The MOSS VRS Spinal System is intended for posterior, non-cervical pedicle fixation for the following indications:

• Degenerative Disc Disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
• Spondylolisthesis
• Trauma (i.e. fractures or dislocations)
• Spinal Stenosis
• Curvatures (i.e. scoliosis, kyphosis and/ or lordosis)
• Tumor
• Pseudoarthrosis
• Failed previous fusion

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the MOSS VRS system is indicated as an adjunct to fusion to treat adolescent idiopathic scolosis. The MOSS VRS system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The Biedermann Motech MOSS VRS Spinal System is a comprehensive thoracolumbosacral spinal system that offers posterior clinical solutions. The MOSS VRS System is a universal set of instruments and implants that are indicated for the treatment of significant mechanical instability or deformity of the spine which requires fusion with instrumentation.

The MOSS VRS System provides several options for stabilization of the spine. Therefore, the system includes the following implants:

• Pedicle Screws Ø4.35-9mm, length 20-100mm
• Rods Ø5,5mm and Ø6,0mm, length 30-95mm, 120-600mm
• Locking Caps
• Polyaxial Reductionheads

The implants of the MOSS VRS System are single-use only and the system is provided non sterile.

This appears to be a 510(k) Summary for a medical device (MOSS VRS Spinal System). The document describes the device, its indications for use, and a comparison to predicate devices, including performance data. However, it does not describe a study involving an AI/Machine Learning device or specific acceptance criteria for such a device in the way your prompt requests.

The performance data section (8.1 Non-Clinical Test Summary) details bench testing for mechanical properties of the physical spinal implant system. It explicitly states, "No clinical tests were performed" (8.2 Clinical Test Summary).

Therefore, I cannot provide the requested information for an AI/ML device because this submission focuses on a traditional medical device (a spinal implant system) and its mechanical performance, not an AI-powered diagnostic or therapeutic tool.

If this document were for an AI/ML device, the requested information would typically be found in dedicated sections outlining the algorithm's performance study.

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The Zavation Spinal System is a pedicle screw system intended to provide Immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Zavation Spinal Systems is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The Zavation Spinal Systems when used as anterior thoracic/lumbar screw fixation systems, is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

The Zavation Spinal System is comprised of polyaxial pedicle screws, rods, and cross connectors. The Zavation Spinal System can be used for single or multiple level fixations. The pedicle screws are available in various lengths and diameters. The rods are available in straight and pre-lordosed (curved) configurations. The system has variable length cross connectors.

The provided document is a 510(k) summary for the Zavation Spinal System, which is a medical device. This document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of device performance as one would typically find for an AI/ML medical device.

Instead, this document describes the Zavation Spinal System, its intended use, materials, predicate devices, and the basis for its substantial equivalence to those predicate devices. The "Performance Data" section specifically states:

"Static compression bending and torsion, and dynamic compression bending were performed according to ASTM F1717 on a worst-case construct. The mechanical test results demonstrated that the Zavation Spinal System performs as well as or better than the predicate devices."

This indicates a mechanical performance study for a spinal implant, which is a different type of evaluation from what is typically done for AI/ML devices regarding diagnostic accuracy or clinical effectiveness.

Therefore, I cannot provide the requested information about acceptance criteria and device performance in the context of an AI/ML device from this document. The document primarily focuses on:

• Mechanical Safety/Performance: Comparing the mechanical strength of the Zavation Spinal System to predicate devices according to a specific ASTM standard (F1717). The acceptance criterion here is implicit: the device must perform "as well as or better than" the predicate devices in these mechanical tests.
• Substantial Equivalence: Arguing that the device is substantially equivalent to legally marketed predicate devices based on technological characteristics, performance, and intended use.

To answer your specific questions in the context of an AI/ML device, I would need a document detailing a clinical performance study or an AI algorithm validation study.

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The FloSpine Canaveral Pedicle System is intended for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

When used for posterior non-cervical pediction in pediatric patients, the Canaveral Pedicle Screw System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Canaveral Pedicle Screw System for pediatric use is intended to be used with autograft. Pediatric pedicle screw fixation is limited to the posterior approach.

The Canaveral Pedicle Screw System is indicated to provide the surgeon with a minimally invasive approach for posterior spine surgery.

The FloSpine Canaveral Pedicle Screw System comprises non-sterile, single use, titanium alloy components for creating a posterior spinal implant construct. The system attaches to the spine through a component system comprising of pedicle screw assemblies for open and minimally invasive procedures, rods, hooks and set screws. The system is designed to stabilize the spine during the fusion process. The screws are available as monoaxial, uniplanar and polyaxial screws in both cannulated and non-cannulated forms. The rods are available as straight and precurved rods and are available in 2 diameters and multiple lengths. Components are made of Ti6Al4V ELI, a titanium based alloy, which complies with ASTM F136. Some rods are made from cobalt chrome which complies with ASTM F1537.

The provided text is a 510(k) Summary for the Canaveral Pedicle Screw System. It outlines the device description, indications for use, and a comparison to predicate devices, along with performance standards for pre-clinical testing.

However, the document does not contain information on acceptance criteria, a study proving the device meets acceptance criteria, sample sizes, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth used, or details about training sets. The primary focus of this document is to establish substantial equivalence to predicate devices for regulatory clearance based on materials, function, sizes, and mechanical test results, as per ASTM F1717-10.

Therefore,Based on the provided document, the following is what can be extracted:

1. Table of acceptance criteria and the reported device performance:
   The document refers to mechanical testing as per ASTM F1717-10, but does not provide specific acceptance criteria values or the device's reported performance against those criteria in a table format. It states that the device is substantially equivalent to predicate devices based on "mechanical test results."

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   This information is not available in the provided text. The document refers to "pre-clinical testing" for mechanical performance but does not specify sample sizes or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
   This information is not applicable and not available. The document describes mechanical performance testing, not a study involving human assessment of images or clinical outcomes that would require expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   This information is not applicable and not available. As above, the testing described is mechanical, not involving human adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
   This information is not applicable and not available. The device is a "Pedicle Screw Spinal System," a physical implant, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   This information is not applicable and not available, as the device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   The "ground truth" for the mechanical testing would be defined by the specified parameters and methodologies of the ASTM F1717-10 standard itself. It's about engineering specifications and material properties, not clinical ground truth.

8. The sample size for the training set:
   This information is not applicable and not available. The document describes a physical medical device, not an AI or machine learning model that would require a training set.

9. How the ground truth for the training set was established:
   This information is not applicable and not available, for the same reason as point 8.

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